Testing, diagnosis, and treatment following the implementation of a program to provide dried blood spot testing for HIV and hepatitis C infections: the NSW DBS Pilot.

BACKGROUND: Dried blood spot (DBS) testing provides an alternative to phlebotomy and addresses barriers to accessing healthcare experienced by some key populations. Large-scale evaluations of DBS testing programs are needed to understand their feasibility. This study evaluated the implementation of a state-wide DBS HIV and hepatitis C virus (HCV) testing pilot. METHODS: The New South Wales (NSW) DBS Pilot is an interventional cohort study of people testing for HIV antibody and/or HCV RNA from DBS samples in NSW, Australia. Participants at risk of HIV/HCV participated in testing via: 1) self-registration online with a DBS collection kit delivered and returned by conventional postal service; or 2) assisted DBS sample collection at 36 community health sites (including drug treatment and harm-minimisation services) and prisons. Participants received results by text (HIV antibody/ HCV RNA not detected) or a healthcare provider (HIV antibody/ HCV RNA detected). The RE-AIM framework was used to evaluate reach, effectiveness, adoption, and implementation. RESULTS: Reach: Between November 2016 and December 2020, 7,392 individuals were tested for HIV and/or HCV (21% self-registration, 34% assisted in community, and 45% assisted in prison). EFFECTIVENESS: Of 6,922 people tested for HIV (19% men who have sex with men, 13% living outside major cities, 21% born outside Australia), 51% (3,521/6,922) had no HIV test in the past two years, 0.1% (10/6,922) were newly diagnosed with HIV, and 80% (8/10) initiated HIV treatment within six months. Of 5,960 people tested for HCV (24% women, 35% Aboriginal and/or Torres Strait Islander, 55% recently injected drugs), 15% had detectable HCV RNA (878/5,960), and 45% (393/878) initiated treatment within six months. Adoption: By the end of 2020, DBS via assisted registration was available at 36 community sites and 21 prisons. IMPLEMENTATION: 90% of DBS cards arriving at the laboratory had the three full spots required for testing; the proportion was higher in assisted (94%) compared to online (76%) registration. CONCLUSIONS: This study demonstrated the feasibility of DBS testing for HIV and HCV in key populations including Aboriginal and Torres Strait Islander peoples, men who have sex with men, people who inject drugs, and demonstrated the utility of DBS in the prison setting.

The NICE Evidence Standards Framework for digital health and care technologies - Developing and maintaining an innovative evidence framework with global impact.

OBJECTIVE: In 2018, the UK National Institute for Health and Care Excellence (NICE), in partnership with Public Health England, NHS England, NHS Improvement and others, developed an evidence standards framework (ESF) for digital health and care technologies (DHTs). The ESF was designed to provide a standardised approach to guide developers and commissioners on the levels of evidence needed for the clinical and economic evaluation of DHTs by health and care systems. METHODS: The framework was developed using an agile and iterative methodology that included a literature review of existing initiatives and comparison of these against the requirements set by NHS England; iterative consultation with stakeholders through an expert working group and workshops; and questionnaire-based stakeholder input on a publicly available draft document. RESULTS: The evidence standards framework has been well-received and to date the ESF has been viewed online over 55,000 times and downloaded over 19,000 times. CONCLUSIONS: In April 2021 we published an update to the ESF. Here, we summarise the process through which the ESF was developed, reflect on its global impact to date, and describe NICE's ongoing work to maintain and improve the framework in the context for a fast moving, innovative field.

Subtype-specific differences in transmission cluster dynamics of HIV-1 B and CRF01_AE in New South Wales, Australia.

INTRODUCTION: The human immunodeficiency virus 1 (HIV-1) pandemic is characterized by numerous distinct sub-epidemics (clusters) that continually fuel local transmission. The aims of this study were to identify active growing clusters, to understand which factors most influence the transmission dynamics, how these vary between different subtypes and how this information might contribute to effective public health responses. METHODS: We used HIV-1 genomic sequence data linked to demographic factors that accounted for approximately 70% of all new HIV-1 notifications in New South Wales (NSW). We assessed differences in transmission cluster dynamics between subtype B and circulating recombinant form 01_AE (CRF01_AE). Separate phylogenetic trees were estimated using 2919 subtype B and 473 CRF01_AE sequences sampled between 2004 and 2018 in combination with global sequence data and NSW-specific clades were classified as clusters, pairs or singletons. Significant differences in demographics between subtypes were assessed with Chi-Square statistics. RESULTS: We identified 104 subtype B and 11 CRF01_AE growing clusters containing a maximum of 29 and 11 sequences for subtype B and CRF01_AE respectively. We observed a > 2-fold increase in the number of NSW-specific CRF01_AE clades over time. Subtype B clusters were associated with individuals reporting men who have sex with men (MSM) as their transmission risk factor, being born in Australia, and being diagnosed during the early stage of infection (p < 0.01). CRF01_AE infections clusters were associated with infections among individuals diagnosed during the early stage of infection (p < 0.05) and CRF01_AE singletons were more likely to be from infections among individuals reporting heterosexual transmission (p < 0.05). We found six subtype B clusters with an above-average growth rate (>1.5 sequences / 6-months) and which consisted of a majority of infections among MSM. We also found four active growing CRF01_AE clusters containing only infections among MSM. Finally, we found 47 subtype B and seven CRF01_AE clusters that contained a large gap in time (>1 year) between infections and may be indicative of intermediate transmissions via undiagnosed individuals. CONCLUSIONS: The large number of active and growing clusters among MSM are the driving force of the ongoing epidemic in NSW for subtype B and CRF01_AE.

Increased HIV Subtype Diversity Reflecting Demographic Changes in the HIV Epidemic in New South Wales, Australia.

Changes over time in HIV-1 subtype diversity within a population reflect changes in factors influencing the development of local epidemics. Here we report on the genetic diversity of 2364 reverse transcriptase sequences from people living with HIV-1 in New South Wales (NSW) notified between 2004 and 2018. These data represent >70% of all new HIV-1 notifications in the state over this period. Phylogenetic analysis was performed to identify subtype-specific transmission clusters. Subtype B and non-B infections differed across all demographics analysed (p < 0.001). We found a strong positive association for infections among females, individuals not born in Australia or reporting heterosexual transmission being of non-B origin. Further, we found an overall increase in non-B infections among men who have sex with men from 50 to 79% in the last 10 years. However, we also found differences between non-B subtypes; heterosexual transmission was positively associated with subtype C only. In addition, the majority of subtype B infections were associated with clusters, while the majority of non-B infections were singletons. However, we found seven non-B clusters (≥5 sequences) indicative of local ongoing transmission. In conclusion, we present how the HIV-1 epidemic has changed over time in NSW, becoming more heterogeneous with distinct subtype-specific demographic associations.

Comparison of Trends in Rates of Sexually Transmitted Infections Before vs After Initiation of HIV Preexposure Prophylaxis Among Men Who Have Sex With Men.

Importance: There have been concerns that HIV preexposure prophylaxis (PrEP) may be associated with increases in sexually transmitted infections (STIs) because of subsequent reductions in condom use and/or increases in sexual partners. Objective: To determine trends in STI test positivity among high-risk men who have sex with men (MSM) before and after the start of HIV PrEP. Design, Setting, and Participants: A before-after analysis was conducted using a subcohort of a single-group PrEP implementation study cohort in New South Wales, Australia (Expanded PreEP Implementation in Communities in New South Wales [EPIC-NSW]), from up to 1 year before enrollment if after January 1, 2015, and up to 2 years after enrollment and before December 31, 2018. STI testing data were extracted from a network of 54 sexual health clinics and 6 primary health care clinics Australia-wide, using software to deidentify, encrypt, and anonymously link participants between clinics. A cohort of MSM dispensed PrEP for the first time during the study, with 2 or more STI tests in the prior year and who tested during follow-up, were included from the EPIC-NSW cohort of HIV-negative participants with high-risk sexual behavior. Data analysis was performed from June to December 2019. Exposures: Participants were dispensed coformulated tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) as HIV PrEP. Main Outcomes and Measures: The main outcome was STI, measured using test positivity, defined as the proportion of participants testing positive for an STI at least once per quarter of follow-up. Outcomes were calculated for Chlamydia trachomatis and Neisseria gonorrhoea by site of infection (anorectal, pharyngeal, urethral, or any) and for syphilis. Results: Of the EPIC-NSW cohort of 9709 MSM, 2404 were included in the before-after analysis. The mean (SD) age of the participants was 36 (10.4) years, and 1192 (50%) were Australia-born. STI positivity was 52% in the year after PrEP (23.3% per quarter; 95% CI, 22.5%-24.2% per quarter) with no significant trend (mean rate ratio [RR] increase of 1.01 per quarter [95% CI, 0.99-1.02]; P = .29), compared with 50% positivity in the year prior to PrEP (20.0% per quarter [95% CI, 19.04%-20.95% per quarter]; RR for overall STI positivity, 1.17 [95% CI, 1.10-1.24]; P < .001), with an increase in quarterly STI positivity (mean RR of 1.08 per quarter, or an 8% increase per quarter [95% CI, 1.05-1.11]; P < .001; RR, 0.93 [95% CI, 0.90-0.96]; P < .001). Findings were similar when stratified by specific STIs and anatomical site. Conclusions and Relevance: STI rates were high but stable among high-risk MSM while taking PrEP, compared with a high but increasing trend in STI positivity before commencing PrEP. These findings suggest the importance of considering trends in STIs when describing how PrEP use may be associated with STI incidence.

Limited Sustained Local Transmission of HIV-1 CRF01_AE in New South Wales, Australia.

Australia's response to the human immunodeficiency virus type 1 (HIV-1) pandemic led to effective control of HIV transmission and one of the world's lowest HIV incidence rates-0.14%. Although there has been a recent decline in new HIV diagnoses in New South Wales (NSW), the most populous state in Australia, there has been a concomitant increase with non-B subtype infections, particularly for the HIV-1 circulating recombinant form CRF01_AE. This aforementioned CRF01_AE sampled in NSW, were combined with those sampled globally to identify NSW-specific viral clades. The population growth of these clades was assessed in two-year period intervals from 2009 to 2017. Overall, 109 NSW-specific clades were identified, most comprising pairs of sequences; however, five large clades comprising ≥10 sequences were also found. Forty-four clades grew over time with one or two sequences added to each in different two-year periods. Importantly, while 10 of these clades have seemingly discontinued, the remaining 34 were still active in 2016/2017. Seven such clades each comprised ≥10 sequences, and are representative of individual sub-epidemics in NSW. Thus, although the majority of new CRF01_AE infections were associated with small clades that rarely establish ongoing chains of local transmission, individual sub-epidemics are present and should be closely monitored.

A priority-driven, policy-relevant research program to support a response to blood-borne viruses and sexually transmissible infections in NSW, Australia.

OBJECTIVES: Strong collaboration between researchers, policy makers and practitioners supports the use of research evidence in policy and practice. Strategies for increasing the use of evidence in policy development and implementation include creating more opportunities for closer collaboration between researchers and policy makers, ensuring research syntheses are more accessible to policy makers, and increasing workforce capacity to utilise evidence. Type of program or service: The BBV & STI Research, Intervention and Strategic Evaluation Program, 2014-2019 (BRISE) is a coherent and integrated program that delivers policy-relevant research, strategic advice, capacity building and communications to support the response to blood-borne viruses (BBV) and sexually transmissible infections (STI) in New South Wales (NSW), Australia. BRISE has five key objectives: generate high-quality research; maximise the use of research; build research capacity; communication and marketing; and governance and management. RESULTS: BRISE facilitates the coproduction of research where researchers and policy makers are meaningfully involved in all stages of research priority setting and codesign from development to application, building an understanding of the way evidence is generated to allow for greater integration between research and use of evidence. LESSONS LEARNT: Bringing multiple research projects together under a single contract and budget provided the NSW Ministry of Health (the Ministry) with cost efficiencies and streamlined contract management and project reporting. A flexible work plan allowed for a mix of longer-term (up to 5-year) projects and shorter projects that were responsive to emerging policy-relevant research priorities. The Ministry became involved in the production of collaborative research as a research partner, rather than solely a research 'funder'. The joint management of research projects involving a policy officer from the Ministry provided opportunities for individuals to build on their research capabilities and literacy. Collaborative priority setting and project work, and increased research literacy, improved the likelihood that research generated would then be used in policy and practice.

Nurse-led pre-exposure prophylaxis: a non-traditional model to provide HIV prevention in a resource-constrained, pragmatic clinical trial.

There is little evidence and no standardised model for nurse-led HIV pre-exposure prophylaxis (PrEP). In 2016, public sexual health clinics in the state of New South Wales (NSW), Australia, participating in the population-scale PrEP access trial Expanded PrEP Implementation In Communities in New South Wales (EPIC-NSW) were authorised to adopt a nurse-led model of PrEP provision in order to facilitate the rapid expansion of PrEP access to more than 8000 participants in under 2 years without additional resources. The model has been implemented successfully in public clinics in 10 of 14 local health districts, with widespread support and no serious safety events reported. With the increasing importance of PrEP as an HIV prevention tool, non-traditional models of care, including nurse-led PrEP, are needed.

USDA food and nutrient databases provide the infrastructure for food and nutrition research, policy, and practice.

The USDA food and nutrient databases provide the basic infrastructure for food and nutrition research, nutrition monitoring, policy, and dietary practice. They have had a long history that goes back to 1892 and are unique, as they are the only databases available in the public domain that perform these functions. There are 4 major food and nutrient databases released by the Beltsville Human Nutrition Research Center (BHNRC), part of the USDA's Agricultural Research Service. These include the USDA National Nutrient Database for Standard Reference, the Dietary Supplement Ingredient Database, the Food and Nutrient Database for Dietary Studies, and the USDA Food Patterns Equivalents Database. The users of the databases are diverse and include federal agencies, the food industry, health professionals, restaurants, software application developers, academia and research organizations, international organizations, and foreign governments, among others. Many of these users have partnered with BHNRC to leverage funds and/or scientific expertise to work toward common goals. The use of the databases has increased tremendously in the past few years, especially the breadth of uses. These new uses of the data are bound to increase with the increased availability of technology and public health emphasis on diet-related measures such as sodium and energy reduction. Hence, continued improvement of the databases is important, so that they can better address these challenges and provide reliable and accurate data.

A structured vocabulary for indexing dietary supplements in databases in the United States.

Food composition databases are critical to assess and plan dietary intakes. Dietary supplement databases are also needed because dietary supplements make significant contributions to total nutrient intakes. However, no uniform system exists for classifying dietary supplement products and indexing their ingredients in such databases. Differing approaches to classifying these products make it difficult to retrieve or link information effectively. A consistent approach to classifying information within food composition databases led to the development of LanguaL™, a structured vocabulary. LanguaL™ is being adapted as an interface tool for classifying and retrieving product information in dietary supplement databases. This paper outlines proposed changes to the LanguaL™ thesaurus for indexing dietary supplement products and ingredients in databases. The choice of 12 of the original 14 LanguaL™ facets pertinent to dietary supplements, modifications to their scopes, and applications are described. The 12 chosen facets are: Product Type; Source; Part of Source; Physical State, Shape or Form; Ingredients; Preservation Method, Packing Medium, Container or Wrapping; Contact Surface; Consumer Group/Dietary Use/Label Claim; Geographic Places and Regions; and Adjunct Characteristics of food.

Summary of an NIH workshop to identify research needs to improve the monitoring of iodine status in the United States and to inform the DRI.

The Office of Dietary Supplements (ODS) at the NIH sponsored a workshop on May 12-13, 2011, to bring together representatives from various NIH institutes and centers as a first step in developing an NIH iodine research initiative. The workshop also provided an opportunity to identify research needs that would inform the dietary reference intakes for iodine, which were last revised in 2001. Iodine is required throughout the life cycle, but pregnant women and infants are the populations most at risk of deficiency, because iodine is required for normal brain development and growth. The CDC monitors iodine status of the population on a regular basis, but the status of the most vulnerable populations remains uncertain. The NIH funds very little investigator-initiated research relevant to iodine and human nutrition, but the ODS has worked for several years with a number of other U.S. government agencies to develop many of the resources needed to conduct iodine research of high quality (e.g., validated analytical methods and reference materials for multiple types of samples). Iodine experts, scientists from several U.S. government agencies, and NIH representatives met for 2 d to identify iodine research needs appropriate to the NIH mission.

White rice sold in Hawaii, Guam, and Saipan often lacks nutrient enrichment.

Rice is a commonly consumed food staple for many Asian and Pacific cultures thus, nutrient enrichment of rice has the potential to increase nutrient intakes for these populations. The objective of this study was to determine the levels of enrichment nutrients (ie, thiamin, niacin, iron, and folic acid) in white rice found in Guam, Saipan (Commonwealth of the Northern Mariana Islands), and Oahu (Hawaii). The proportion of white rice that was labeled "enriched" varied by type, bag size, and location. Most long-grain rice was labeled as enriched and most medium-grain rice was not. Bags of either type weighing >10 lb were seldom labeled as enriched in Hawaii or Saipan. Samples of various types of rice were collected on these three islands (n=19; 12 of which were labeled as enriched) and analyzed for their content of enrichment nutrients. Rice that was labeled as enriched in Hawaii and Guam seldom met the minimum enrichment standards for the United States. For comparison, three samples of enriched rice from California were also analyzed, and all met the enrichment standards. Food and nutrition professionals who are planning or evaluating diets of these Pacific island populations cannot assume that rice is enriched.

Towards establishing dietary reference intakes for eicosapentaenoic and docosahexaenoic acids.

There is considerable interest in the impact of (n-3) long-chain PUFA in mitigating the morbidity and mortality caused by chronic diseases. In 2002, the Institute of Medicine concluded that insufficient data were available to define Dietary Reference Intakes (DRI) for eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA), noting only that EPA and DHA could contribute up to 10% toward meeting the Adequate Intake for alpha-linolenic acid. Since then, substantial new evidence has emerged supporting the need to reassess this recommendation. Therefore, the Technical Committee on Dietary Lipids of the International Life Sciences Institute North America sponsored a workshop on 4-5 June 2008 to consider whether the body of evidence specific to the major chronic diseases in the United States--coronary heart disease (CHD), cancer, and cognitive decline--had evolved sufficiently to justify reconsideration of DRI for EPA+DHA. The workshop participants arrived at these conclusions: 1) consistent evidence from multiple research paradigms demonstrates a clear, inverse relation between EPA+DHA intake and risk of fatal (and possibly nonfatal) CHD, providing evidence that supports a nutritionally achievable DRI for EPA+DHA between 250 and 500 mg/d; 2) because of the demonstrated low conversion from dietary ALA, protective tissue levels of EPA+DHA can be achieved only through direct consumption of these fatty acids; 3) evidence of beneficial effects of EPA+DHA on cognitive decline are emerging but are not yet sufficient to support an intake level different from that needed to achieve CHD risk reduction; 4) EPA+DHA do not appear to reduce risk for cancer; and 5) there is no evidence that intakes of EPA+DHA in these recommended ranges are harmful.

Legacy of Wilbur O. Atwater: human nutrition research expansion at the USDA--interagency development of food composition research.

The systematic chemical analysis of foods for human consumption in the United States had its origin with Wilbur O. Atwater. This activity began in the 1860s while Atwater was a student at Yale University and continued through his tenures at Wesleyan University and the Storrs (Connecticut) Experiment Station. These activities moved with Atwater to the USDA in Washington, DC and ultimately to the Henry D. Wallace Beltsville Agricultural Research Center in Beltsville, MD early in the 1900s. During the first half of the 20th century, food composition activities were guided by the discovery of new essential nutrients and the need to measure and tabulate their levels in foods. Later in the century, the association between diet and chronic diseases was recognized. As a result, collaborations were established between other food- and health-related government agencies, the food industry, and many universities. At the same time, computer and communication technology greatly advanced, which became integral to laboratory instrumentation and allowed data in the National Nutrient Databank System to be available electronically. Simultaneously, accuracy of analytical data came under scrutiny and a new paradigm was established in collaboration with governmental metrology units worldwide. Advances in computer technology and the increased focus on accuracy of analytical data subsequently led to the development of quality indicators for all food composition data. Recently, increased consumption of dietary supplements resulted in the broadening of food composition efforts and development of new collaborations with government agencies, several industries, and universities.

Assessing vitamin D contents in foods and supplements: challenges and needs.

Scientists need specific data on the amounts of vitamin D in foods and dietary supplements to facilitate the assessment of vitamin D dietary intake. This vitamin is available in foods both naturally and from fortification. The Nutrient Data Laboratory of the US Department of Agriculture (USDA) is collaborating with vitamin D experts to review and develop methods for analyzing the vitamin D content of foods and to use these methods to analyze the vitamin D content of certain foods and dietary supplements. In this article, we review existing sources of vitamin D data on foods and dietary supplements, describe the USDA's Dietary Supplements Ingredients Database, and discuss the development of the USDA's vitamin D database for foods. In addition, we define the challenges and needs related to providing updated data on the vitamin D content of foods and supplements. After we analyze the vitamin D content of these food samples, we will disseminate the current values in the National Nutrient Database for Standard Reference (Internet: http://www.ars.usda.gov/nutrientdata).